FDA UDI
In Commercial Distribution
🇺🇸 United States
GBUK GROUP LIMITED
DI: 04719873438303
·
Model: CDT-001
·
Pacific Hospital Supply Company Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GBUK GROUP LIMITED
- Primary DI
- 04719873438303
- Version / Model
- CDT-001
- Company Name
- Pacific Hospital Supply Company Limited
- Labeler DUNS
- 656117801
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-18
- Public Version
- 4
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- 756e6603-bf1c-411b-9431-f4e7bfa6a473
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAZ | Tubing, Noninvasive | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47338 | Suction system container stand | A device in the form of a floor-standing base, frame, and/or pole designed to provide stability for one or more suction/drainage containers (e.g., suction canisters, drainage bags or bottles) during a procedure. It may have partitions for the containers, a handle(s) and/or wheels to assist with transport. It is not intended to hold capital equipment (i.e., not pumps), and is not primarily used for transport of the containers (i.e., it is not a trolley); the containers are not included with the stand. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24719873438307 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04719873438303 | GS1 |